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July 16, 2009

Swine Flu Pandemic Could Trigger Vaccine Battles

by Sam Savage

A potential squabble is taking shape over the vaccine for the H1N1 virus, as governments fall under pressure to protect their own citizens first before allowing firms who make the virus to ship the vaccine abroad.

Furthermore, some nations could find their vaccine contracts with pharmaceutical firms are easily broken.

With some 70 percent of the world's flu vaccines produced in Europe, only a small number of countries are self-sufficient in vaccines.

Nations such as the U.S., which produces just 20 percent of the flu vaccine it uses, and Britain, which makes none of its vaccines, could face challenges as a result.

Since factories cannot be built overnight, it is a problem that can't be fixed overnight.

"This isn't rocket science," Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, told the Associated Press.

"If there is severe disease, countries will want to hang onto the vaccine for their own citizens," he said.

Politicians would likely succumb to pressure to keep the vaccines in their own country, experts say.

"The consequences of shipping vaccine to another country when your own people don't have it would be devastating," retired vaccine industry executive David Fedson told the AP.

Worldwide, nearly 95,000 cases of swine flu, including 429 deaths, have been reported, the World Health Organization (WHO) said last week.

Should the virus become more deadly this winter, nations will be scrambling for any available vaccines.

"Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine," said David Fidler, an Indiana University law professor who has consulted for the WHO.

"We've seen how countries behave in those situations, and it's not encouraging," he told the AP.

Britain said it would begin vaccinating people in August, while Italy said it will initiate a vaccination program at the end of the year. Many other countries are adopting similar strategies. However, these plans could get derailed by problems with vaccine production and by other countries' refusal to ship the vaccine abroad.

Indeed, in previous pandemics or global epidemics, vaccines were never exported before the nation that made them got enough for its own population first.

This time, however, many countries have signed contracts with vaccine-makers to guarantee first access to the vaccine.

But some say these contracts may be meaningless in the face of a true global health crisis.

For instance, countries with flu vaccine facilities might choose to seize all vaccines and ban their export. Doing so would prevent the vaccine makers from honoring their contracts to other countries.

According to Fidler, these private contracts are not binding international law, and most vaccine contracts include a provision allowing them to be broken under extraordinary circumstances such as a global health crisis.

If that were to happen, nations that held such contracts would be without the vaccine or any legal recourse.

"There's nothing in international law that helps you resolve this, it's just a political nightmare happening in the midst of an epidemiological nightmare," Fidler added.

Britain has ordered 60 million doses of H1N1, enough to vaccinate its entire population, from GlaxoSmithKline PLC and Baxter International Inc. But production facilities for these firms are in Germany, Austria and the Czech Republic.

Roughly 80 percent of the United States' pandemic vaccine supply will be coming from overseas, according to Osterholm, who said he was concerned when the doses might arrive. The timing of vaccine delivery can be critical during times of a severe flu outbreak.

"It's easy to move vaccine around if the disease is relatively mild. But if it is more severe, countries may not be willing to let it go," he said.

To date, the swine flu has remained relatively mild, with the majority of those who become infected recovering on their own without medical treatment.

But experts worry the virus could mutate into a more lethal form, particularly during the flu season when the virus spreads more easily. If that were to happen more people would likely fall sick and die.

Although government health officials are well aware that "vaccine wars" could emerge if the pandemic worsens, they dread even speaking about the subject.

The European Centre for Disease Prevention and Control told the AP it had no mandate to advise countries in such circumstances. Meanwhile, the WHO said it was not aware of any countries planning to block vaccine shipments, and said they would work to ensure all countries received enough doses to vaccinate their health workers.

It is not yet clear when a swine flu vaccine will be available. The WHO said earlier this week that a fully licensed vaccine might not be ready until the end of the year.

Given the scarce safety data about a swine flu vaccine, governments are taking a risk in rolling out mass vaccination programs since any rare side effects won't appear until millions of people have received the shots.

Experts are skeptical of government timetables for rolling out their vaccination programs.

"Many pieces of the puzzle are missing," Osterholm said.

"Anyone who pretends to have a well-defined schedule of vaccine delivery is obviously very poorly informed," he said.

Experts estimate the swine flu will be about as dangerous as seasonal flu, which typically flu kills up to 500,000 people annually.